510(k) K925228

IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL by Y — Product Code FPA

K925228 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL". The FDA issued a decision of Substantially Equivalent on July 30, 1993. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Y has at least 10 other 510(k) clearances on record.